Clearant is an autonomous AI agent that monitors regulatory changes, generates compliance documentation, and prepares submissions for MedTech companies. No prompting. No babysitting. It just works.
Open Change Monitor →Clearant continuously monitors EU MDR, FDA, ISO 13485, and MDSAP sources. New requirements are parsed, structured, and mapped to your product portfolio automatically.
When regulations change, Clearant identifies which of your products are affected, what documentation needs updating, and the downstream impact on your quality system.
Compliance documents are generated, technical files are updated, and submission packages are prepared. You review and approve. The agent handles the rest.
Tracks EU MDR, FDA 21 CFR, ISO 13485, IEC 62304, MDSAP, and dozens of international standards in real-time. You never miss a change.
Produces technical documentation, clinical evaluation reports, risk management files, and GSPR checklists from your product data.
When requirements change, Clearant maps the impact across your entire product portfolio and quality management system within minutes.
Monitors adverse events, field safety notices, and PMCF requirements. Generates periodic safety update reports on schedule.
Clearant closes the gap between what regulators demand and what teams can deliver. MedTech moves faster when compliance runs autonomously.
See It In Action →